Originating from Saint Paul, MN, Doctor Pundit is all about the intersection between healthcare policy, science, politics, and all surrounding points and issues. Although the entire scope of healthcare delivery and policy is much too encompassing for just one blogger to cover, I'll try my best. Enjoy! From time to time, you'll also see other items of interest that probably have nothing to do with health policy in the least. Try and keep an open mind. :) Proprietor & Editor -- Michael Douglas, MD, MBATag Archives for GSK
Pharma Company Forges Partnership to Create Genetic Therapies for Rare Diseases
In an otherwise dull year for novel drug development, GSK is making positive news; it plans to expand into the realm of pharmaceutical development for the treatments of rare disorders. While this seems very noble for what it is, one … Continue reading
FDA: Keep Avandia on Market, Impose Ponderous Restrictions on Use
The FDA has announced today Avandia’s official indication. After months of teetering on the brink of availability many times over, GSK’s once star performer has now been relegated to last-ditch status. As of today, Avandia will be restricted to patients … Continue reading
FDA Tells Pharma Co. to Halt Recruitment for Its Own Safety Trial
Embattled pharma company GSK may be celebrating the continued availability of its once-blockbuster drug Avandia on the market, but it’s bemoaning the fact that the FDA is putting the breaks (halting recruitment) on a safety trial it has begun initiating … Continue reading
FDA: Avandia Stays on Market
The vote is 20-12 against withdrawing GSK’s troubled drug Avandia from the marketplace. Essentially, the FDA says that — in spite of the earlier vote the committee had on positively acknowledging the cardiac risks associated with the drug — those … Continue reading
FDA Discussions on Avandia Enter 2nd Day
As the debate over Avandia enters its second day, more controversy is sure to erupt. With both sides clinging to inexplicable minutiae as much as they are to the major points defining this hefty FDA review, the outcome will probably … Continue reading
Report: Pharma Company Covered Up Known Cardiovascular Risks of Drug
GSK (then known as SmithKline Beecham) knew in a 1999 trial that Avandia, the drug undergoing scrutiny on its fate in the pharma marketplace today, posed a signficant cardiac risk when compared to its major competitor Actos — and it … Continue reading
FDA to Decide Fate of Diabetes Drug This Week
It’s official. The FDA will convene this Tuesday (13) to discuss and come to a decision on the fate of GSK’s Avandia. I guess you could literally call this agent a wonder drug — as its continued availability in the … Continue reading
Diabetes Drug Once Again under Scrutiny
A couple of weeks before the FDA meets to discuss the safety of the antidiabetic medication Avandia come (coincidentally) more reasons this agent should be withdrawn from the pharma marketplace. One study concludes that Avandia increased the risk of death, … Continue reading
Report: Pharma Amplified Global H1N1 Scare
What is known about the H1N1 epidemic that plagued the world in 2009 was its influence in global approach to this infection — for good or bad — and the costs to nations which chose to meet its threat head … Continue reading
FDA Considers Ending Troubled GSK Drug’s Involvement in Safety Study
Add yet another blow to GSK’s once-blockbuster diabetes drug, Avandia (rosiglitazone). The ongoing soap opera that is this drug’s manufacture and continued presence begins another chapter in its struggle to retain some semblance of competition in the pharma marketplace. Avandia’s … Continue reading
Pharma Company Goes on the Defensive Amid New Avandia Attacks
A safety review of GSK’s Avandia, under fire and intense scrutiny for its role in the possible development of cardiac adverse effects is nearing completion. In spite of the continued negative press, the pharma company has issued a thirty page … Continue reading
Two Major Pharma Companies Announce Joint Venture
Glaxo (GSK) and Pfizer aim to create a new HIV drug company. Both drugs have a financial stake in the matter as both entities’ current products are essentially devoid of further innovation. GSK’s lack of new product (it’s already the … Continue reading
